Study on Chemoradiation and Biomarkers for High-Risk Breast Cancer

Sponsor: University of Virginia

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05288777

Provider View

This clinical trial is exploring the safety and effectiveness of combining chemotherapy and radiation therapy after surgery in patients with high-risk breast cancer who still have some cancer left after initial treatment. The study also looks at how this treatment affects the immune system.

Patient Parameters

Program Overview

The study aims to find out if combining chemotherapy and radiation therapy after surgery can help control high-risk breast cancer in patients who still have cancer remaining after initial chemotherapy and surgery. Researchers will also examine how this treatment affects the immune system.

Description

Breast cancer treatment often involves surgery, chemotherapy, and radiation. For advanced cases, chemotherapy is given before surgery to shrink tumors. However, if cancer remains after this initial treatment, there's a higher risk of it coming back. This study is testing if adding chemotherapy and radiation after surgery can improve outcomes for high-risk patients. This approach is common in other cancers but not typically used for breast cancer after surgery.

Participants will receive either capecitabine or Trastuzumab emtansine (T-DM1) based on their cancer type, along with radiation therapy. Blood samples will be taken at different times to monitor health, and participants will complete surveys about their well-being.

Eligibility Criteria

Inclusion Criteria

  • Signed consent form and willingness to follow study procedures
  • Aged 18 or older, male or female
  • Diagnosed with stage I-IIIB breast cancer
  • Received at least 3 cycles of chemotherapy and had surgery (lumpectomy or mastectomy)
  • Still have some cancer left after surgery
  • Eligible for additional chemotherapy and radiation as part of standard care
  • Radiation planned within 12 weeks after surgery
  • Good overall health with a performance status of 0 to 2
  • Heart function adequate for those receiving T-DM1
  • Sufficient blood cell counts and organ function based on lab tests
  • Agree to use contraception during and after the study
  • Willing to follow lifestyle guidelines during the study
  • If taking warfarin and prescribed capecitabine, anticoagulant management must be assessed before treatment

Exclusion Criteria

  • Had mastectomy with expander or immediate reconstruction
  • Diagnosed with lupus or scleroderma
  • Genetic mutation increasing sensitivity to radiation
  • Active bacterial or fungal infection needing IV antibiotics
  • Evidence of cancer spread
  • Pregnant or breastfeeding
  • Incarcerated
  • Cardiac pacemaker on the treatment side unless it can be moved
  • High exposure to certain chemotherapy drugs
  • Allergic to capecitabine or T-DM1
  • Known DPD deficiency if prescribed capecitabine
  • Fever within a week of starting treatment
  • Incomplete healing of surgery site within 12 weeks
  • Known HIV or active hepatitis
  • Unwilling to stop endocrine therapy if currently taking it

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